FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
70518-3359
11-digit product format
705183359
Labeler code
70518
Product ID
70518-3359_4ef45bc9-bc03-4a8d-e063-6394a90a0f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2022-02-07
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3359-0Valacyclovir Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED48
70518-3359-1Valacyclovir Hydrochloride21 in 1 BOTTLE, PLASTICTABLET, FILM COATED218
70518-3359-2Valacyclovir Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
70518-3359-3Valacyclovir Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED148

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir 1000 MG Oral TabletSCDde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir 1 GM Oral TabletSYde96c14b-cd74-46dd-bcce-d1fa640a60378

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3359-0705183359004 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3359-0) 2022-02-070000-00-00NoNoCurrent
70518-3359-17051833590121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3359-1) 2022-02-140000-00-00NoNoCurrent
70518-3359-27051833590230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3359-2) 2025-10-14NoNoHistorical
70518-3359-37051833590314 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3359-3) 2026-02-18NoNoHistorical